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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03683134
Other study ID # The Healthy Hearts Program
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 23, 2017
Est. completion date September 7, 2017

Study information

Verified date September 2018
Source Auburn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A 12-week, randomized nutrition intervention for the reduction of cardiovascular disease risk factors in a high-risk population in the southeastern United States. The primary objective of this pilot study was to assess the efficacy of a Mediterranean diet intervention (education + extra-virgin olive oil (EVOO) and mixed nut supplementation) versus that of an American Heart Association (AHA) nutrition intervention (education) on serum blood lipid levels as markers for cardiovascular disease risk. Researchers conducting this trial hypothesize that a greater reduction will be seen in cardiovascular disease risk factors in the Mediterranean diet intervention.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date September 7, 2017
Est. primary completion date September 7, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Enrolled in Auburn University's health insurance program during the course of the study or a dependent of the enrollee during the course of the study

- BMI >24.9 (kg/m2)

- AND Meets two or more of the following

- Screening values classified in the "yellow" or "red" zone for:

- Systolic blood pressure (mmHg): Yellow zone: =140, Red zone: =160;

- Diastolic Blood pressure (mmHg): Yellow zone: =90, Red zone: = 100;

- Fasting blood glucose (mm/dL): Yellow zone: =100, Red zone: = 126

- Blood glucose (random) (mg/dL): Yellow zone: 140-200, Red zone > 200

- Total Cholesterol (mg/dL): Yellow zone: =200, red zone: =250

- Have a pre-existing diagnosis of hypertension, pre-diabetes, or hypercholesterolemia

- Current smoker (=1 cigarette/day)

- Are: male (age: 55-80) or female (age: 60-80)

- A family history of premature coronary heart disease

- High risk ethnicity: Black, African American, American Indians/Alaska Natives, Non-Hispanic blacks, Mexican-Americans, Asian, Hispanic/Latino

Exclusion Criteria:

- Minors that are less than 19 years of age

- Individuals who are not enrolled in the Auburn University health insurance program for the 2016 plan year at baseline and have not yet completed initial visit

- Individuals who have not completed their 2015 "Healthy Tigers" biometric screening between January 1st and December 31st, 2015 (these can be completed by the "Healthy Tigers" staff or by submitting a healthcare provider form from the individuals' physician to the "Healthy Tigers" office), unless enrolled in "TigerMeds".

- Individuals who are pregnant or who intend to become pregnant during the 12-week health and wellness challenge.

- Individuals who anticipate absence or travel throughout the study that would interfere with their ability to complete the analysis at the mid-point and end of challenge.

- Patients with a peanut, tree nut, or olive oil food allergy or intolerance.

- Patients who are unable or unwilling to travel to Auburn University main campus for live health and wellness challenge events, individual assessments, personal appointments, and pre- and post- data collection

- Individuals who have NOT been stabilized on medication to treat or manage high blood pressure, high cholesterol, dyslipidemia, or pre diabetes for at least 12 weeks prior to the study.

- Patients who do not have access to the internet and therefore unable to complete the education portion of the study

- Individuals who have a pacemaker

- Patients who decline participation during informed consent

Study Design


Intervention

Behavioral:
Mediterranean diet
Participants will receive nutrition education and educational materials from a registered dietitian on patients on the patterns of a Mediterranean style diet. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.
Dietary Supplement:
Olive oil and mixed nuts
Participants in the Mediterranean diet group will receive 3 liters of extra-virgin olive oil and 3 pounds of mixed nuts (1.5 pounds raw almonds and 1.5 pounds raw walnuts) at baseline and at 6 weeks. Participants will be educated by oral and written means, on consumption goals of the nuts and olive oil.
Behavioral:
American Heart Association
Participants will receive nutrition education and educational materials from a registered dietitian on patients on the dietary recommendations from the American Heart Association for heart health. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.

Locations

Country Name City State
United States Auburn University Pharmaceutical Care Center Auburn Alabama

Sponsors (1)

Lead Sponsor Collaborator
Auburn University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Systolic Blood Pressure Measurement Measured in mmHg Change from at baseline blood pressure to 6-weeks
Primary Systolic Blood Pressure Measurement Measured in mmHg Change from at baseline blood pressure to 12-weeks
Secondary Diastolic Blood Pressure Measurement Measured in mmHg Change from at baseline weight to 6-weeks
Secondary Change in Weight Measured in kilograms (kg) Change from at baseline weight to 12-weeks
Secondary Calculation of Body Mass Index (BMI) (kg/m?2) Height in meters will be combined with weight in kilograms will be combined to report BMI in kg/m?2) Change from baseline weight to 6-weeks
Secondary Calculation of BMI (kg/m?2) Height in meters will be combined with weight in kilograms will be combined to report BMI in kg/m?2) Change from baseline weight to 12-weeks
Secondary Concentration of fasted total cholesterol Measured in mg/dL Change from baseline weight to 6-weeks
Secondary Concentration of fasted total cholesterol Measured in mg/dL Change from baseline weight to 12-weeks
Secondary Concentration of fasted high-density lipoprotein (HDL) cholesterol Measured in mg/dL Change from baseline weight to 6-weeks
Secondary Concentration of fasted high-density lipoprotein (HDL) cholesterol Measured in mg/dL Change from baseline weight to 12-weeks
Secondary Concentration of fasted low-density lipoprotein (LDL) cholesterol Measured in mg/dL Change from baseline weight to 12-weeks
Secondary Concentration of fasted low-density lipoprotein (LDL) cholesterol Measured in mg/dL Change from baseline weight to 6-weeks
Secondary Concentration of fasted triglycerides Measured in mg/dL Change from baseline weight to 6-weeks
Secondary Concentration of fasted triglycerides Measured in mg/dL Change from baseline weight to 12-weeks
Secondary A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio Total cholesterol (mg/dL) will be used with HDL (mg/dL) to calculate total cholesterol to HDL ratio Change from baseline weight to 12-weeks
Secondary A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio Total cholesterol (mg/dL) will be used with HDL (mg/dL) to calculate total cholesterol to HDL ratio Change from baseline weight to 6-weeks
Secondary Concentration of fasted blood glucose Measured in mg/dL Change from baseline weight to 6-weeks
Secondary Concentration of fasted blood glucose Measured in mg/dL Change from baseline weight to 12-weeks
Secondary A calculation of waist (inches) to height (inches) ratio Waist circumference in inches will be calculated with height measurement in inches to report the waist-to-height ratio Change from baseline weight to 12-weeks
Secondary A calculation of waist (inches) to height (inches) ratio Waist circumference in inches will be calculated with height measurement in inches to report the waist-to-height ratio Change from baseline weight to 6-weeks
Secondary Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin Fasting plasma glucose in mg/dL and fasting serum insulin in milliUnits (mU)/I will be used to calculate HOMA-IR as an indicator for insulin resistance. Change from baseline weight to 6-weeks
Secondary Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin Fasting plasma glucose in mg/dL and fasting serum insulin in mU/I will be used to calculate HOMA-IR as an indicator for insulin resistance. Change from baseline weight to 12-weeks
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